A&D Engineering, Inc.: FDA clearances and approvals
A&D Engineering, Inc. has 34 FDA 510(k) clearances (first 1987, latest 2008), across 5 product codes in 2 review panels. Median 510(k) review time: 82 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 25 | 25 |
| DSK | Computer, Blood-Pressure | 6 | 6 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Cardiovascular (33)
- General Hospital (1)
Most recent A&D Engineering, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082734 | A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR | DXN | 2008-11-13 | 56 |
| K062027 | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | DXN | 2007-01-19 | 185 |
| K061456 | A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR | DXN | 2006-06-21 | 27 |
| K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | DXN | 2005-03-03 | 101 |
| K042967 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | DXN | 2004-12-03 | 36 |
| K040371 | A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR | DXN | 2004-05-19 | 92 |
| K040229 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 | DXN | 2004-03-19 | 46 |
| K032499 | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | DXN | 2003-10-30 | 78 |
| K012472 | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | DXN | 2002-02-15 | 197 |
| K012013 | LIFESOURCE MODELS UA-787, UA 787PC, UA-787T | DXN | 2001-07-13 | 15 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named A&D Engineering, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does A&D Engineering, Inc. have?
A&D Engineering, Inc. has 34 FDA 510(k) clearances (first 1987, latest 2008), across 5 product codes in 2 review panels.
How long does FDA take to clear A&D Engineering, Inc.'s 510(k)s?
The median time from FDA receipt to decision across A&D Engineering, Inc.'s cleared 510(k)s is 82 days.
What devices does A&D Engineering, Inc. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 25); DSK (Computer, Blood-Pressure, 6); DRQ (Amplifier And Signal Conditioner, Transducer Signal, 1).
Has A&D Engineering, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching A&D Engineering, Inc. Related entities may recall under other names.
Next steps
- See all 34 A&D Engineering, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, A&D Engineering, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.